SOUND AND VIBRATION GENERATOR AND SYSTEM AND METHOD FOR SOUND AND VIBRATION ANALYSIS - Patent application

Abstract

A sound and vibration generator, a method and a system for sound and vibration analysis of tissue processing during surgery, the sound and vibration generator comprising a vibrating element and integrated into a processing means of a surgical instrument, the system and method being adapted to generate the sounds and vibrations by a signal and vibration generator, receive the generated sounds and vibrations by one or more signal receivers, and process the generated sounds and vibrations to determine at least one of a pre-breakthrough stage, a breakthrough event, a moment of transition from a first layer of tissue to a second layer of tissue, or a position of the processing means.

Description

[Technical field]

[0001] The present disclosure relates generally to sound and vibration analysis, and more particularly to sound and vibration analysis associated with tissue processing during surgery.

[0002] During surgical procedures involving bone cutting, sensitive tissues (usually soft tissues) can be compromised or damaged. A dangerous case, called a breakthrough event, occurs when the cutting instrument penetrates into the space on the other side of the bone or inside a groove or cavity in the bone. In such cases, limited visual access can prevent the surgeon from understanding the situation and may not be able to react in time to avoid contact and damage to soft or sensitive tissues.

[0003] In recent years, there have been advances in methods that utilize signal processing of bone sounds and vibrations. A technical challenge with this approach is that traditional surgical tools such as burrs and saws have always been designed and developed to cut bone with minimal vibration and sound generation, or vibration has been perceived as a nuisance and attempts have been made to reduce it. Furthermore, signals resulting from bone processing are transient and depend on multiple factors.

[0004] Cutting or cutting bone generates vibrations, which in turn generate acoustic and vibration signals that can be used to characterize bone types and detect breakthroughs. It is known that during surgery, sound and vibrations cannot be controlled, so sound analysis of hard tissue processing during surgery is not accurate.

[0005] Therefore, there is a need for controllable, safe and precise techniques to avoid damaging soft, sensitive or unwanted tissues during surgery.

[0006] It is an object of the present disclosure to provide systems and methods that prevent damage to soft or sensitive tissues beneath bones, or to blood vessels, nerves, or interior passageways or cavities, such as sinuses.

[0007] The objects of the present disclosure are achieved by a sound and vibration generator and a method for sound and vibration analysis of tissue during surgery as defined in the attached independent claims to which reference is made. Advantageous features are set out in the attached dependent claims.

[0008] Machining bone generates vibrations that result in the generation of acoustic signals. The acoustic signals can be used to characterize bone types and detect breakthroughs. It is an object of the present disclosure to provide a solution for predicting and / or detecting breakthrough events while milling or cutting bone. Furthermore, the systems and methods according to the present disclosure can be utilized to classify bone layers, for example to distinguish cancellous bone from cortical bone. The mechanical sound and vibration generator according to the present disclosure is an additional signal source utilized in signal processing to determine the position of the surgical tool.

[0009] A further advantage of the present disclosure is that the vibration response of bone can be processed to assess bone condition and other properties of bone such as density, hardness, thickness, etc.

[0010] During hard tissue processing, the processing tool penetrates an area or layer of bone and penetrates into an area or layer adjacent to the bone or into soft tissue. To prevent unnecessary damage to the hard or soft tissue, it is necessary to know when to stop drilling. To do so, it is necessary to determine the location of the processing tool in the hard tissue. Thus, the present disclosure provides a surprisingly efficient solution for controllably generating sound and vibration signals that are used to prevent damage to soft, sensitive or unwanted tissue during surgery. [Brief description of the drawings]

[0011] BRIEF DESCRIPTION OF THE DRAWINGS The foregoing summary, as well as the following detailed description of exemplary embodiments, will be better understood when read in conjunction with the appended drawings, in which: For purposes of illustrating the disclosure, exemplary configurations of embodiments of the disclosure are shown in the drawings with reference to the following figures: [Figure 1] FIG. 1 is a diagram illustrating a configuration of an acoustic analysis system. [Diagram 2] FIG. 1 illustrates an example of a sound and vibration generator integrated with a bar device. [Diagram 3] 1 shows the head of the bar device. [Figure 4] 1 illustrates several cutting scenarios according to one embodiment of the present disclosure. [Diagram 5] FIG. 13 illustrates an example of an analysis of generated sound and vibration, FFT spectrum, of a device according to an embodiment of the present disclosure. [Figure 6] 1 shows a system for analyzing sounds and vibrations of tissue processing during surgery. [Figure 7] 1 is a table summarizing signal correlations at several positions of a processing tool. [Figure 8] FIG. 1 shows an example of a frequency spectrum analysis of a surgical instrument consisting of a sound and vibration generator. [Figure 9] 1 shows another example of a frequency spectrum analysis of a conventional cutting burr. [Figure 10] FIG. 1 is a side view of a surgical instrument depicting a sound and vibration generator. [Figure 11] FIG. 11 is a cross-sectional view of the surgical instrument of FIG. 10 along line AA. [Figure 12] FIG. 11 is a cross-sectional view of the surgical instrument of FIG. 10 along line AA. [Figure 13] FIG. 1 is a side view of a surgical instrument depicting a sound and vibration generator. [Figure 14] FIG. 1 is a bottom view of the surgical instrument, depicting the sound and vibration generators. [Figure 15] FIG. 15 is a cross-sectional view of the surgical instrument of FIG. 14 along line AA. [Figure 16] FIG. 1 is a side view of a surgical instrument depicting a sound and vibration generator having a fixed vibrating element. [Figure 17] FIG. 1 is a side view of a surgical instrument depicting a sound and vibration generator having a fixed vibrating element. Detailed Description of the Embodiments

[0012] Throughout this disclosure, the following terms are used with the following meanings.

[0013] Processing may be any of cutting, drilling, milling, polishing, sawing, and grinding.

[0014] The surgical tool may be an oscillating saw, a rotary saw, a reciprocating saw, a sagittal saw, a drill bit, a reamer, a mill, a burr, etc. The surgical tool may be a burr with a working means having a spherical, ovoid, pear-shaped, conical, cylindrical, eggplant-shaped, or a combination of these shapes.

[0015] The tissue processing means may be a vibrating blade, a reciprocating blade, a vibrating blade, a rotating drill bit, a rotating cylindrical burr, a rotating mill, or a rotating burr.

[0016] The tissue may be hard tissue, bone tissue, cartilage tissue, mineralized tissue, dental tissue, tendon tissue, ligament tissue, or may represent a foreign body in the body.

[0017] The surgery may be orthopedic surgery, neurosurgery, spinal surgery, Otolaryngology-Head and Neck surgery, Ear, Nose and Throat (ENT) surgery, dental surgery, and the like.

[0018] In some embodiments of the present disclosure, the cutting sound can be analyzed by an acoustic analysis system that includes the following elements: · Microphone: Captures the cutting sound and converts it into an electrical signal. · Data Acquisition System: Takes the microphone output and converts it into a digital / analog signal that can be analyzed. Processor: A combination of hardware and necessary software to analyze the signal (e.g. detect sound frequency and amplitude), and the system is responsible for identifying / predicting breakthroughs based on known patterns, which could be a sudden drop in sound amplitude or the appearance / disappearance of a particular sound frequency in the FFT spectrum of the signal. User Interface: For communicating with the user. It can use displays, indicators, buzzers, vibrators, etc.

[0019] The various sources of vibration and sound during the bone cutting process that can be used for analysis include: · Friction between the rotating cutting edge or grinding surface and the bone. Chip formation (bone breaking into small pieces). The "Prevention means" feature of the EP3525691B1 patent. A special sound-generating feature is provided on the cutting means of the surgical instrument (e.g. the tip of the cutter).

[0020] It should be noted that the mentioned sound sources can be utilized individually or in combination for the above purposes, and therefore the scope of the present invention is not limited to the sound of the blocking means of said patent moving.

[0021] Acoustic Analysis of the Stopping Means. For the aforementioned purpose, the sound of the stopping means of various bone cutting tools can be analyzed. Also, special sound generating elements can be added to emit specific sounds, for example when the ring (112) rotates or moves radially more than a certain amount during cutting. In some embodiments of the said patent, in the case of the instrument (100), the movable ring (112) hits the internal step (202) and generates a identifiable sound that depends on the bone material, thickness, drill speed, and the force applied by the surgeon to the drill. The sound signal characteristics, such as frequency, amplitude, and their changes, convey information about the status of the bone cutting process. The following table and FIG. 4 explain how the position of the burr head relative to the bone correlates with the sound.

[0022] Table 1: Expected sounds in various cutting scenarios. TIFF2025508754000002.tif133170

[0023] The sound of the device (100) during the various stages of the cutting process was analyzed and its FFT spectrum is shown in Figure 5. The rotational speed of the cutting tool is 617 rounds per second. As a result, the frequencies corresponding to the ring movements are multiples of the frequency of 617 Hz, i.e. 617, 1234, 1851, 2468, etc.

[0024] Other Sound Sources. As previously mentioned, the cutting sounds of other cutting devices, including the patented device and other prior art devices, can be analyzed by the present invention in a similar manner to the examples provided above. The acoustic analysis can be combined with other measurements such as cutting force, vibration, motor torque, or RPM to increase reliability.

[0025] Thus, in accordance with the present disclosure, a system is described for characterizing tissue types and detecting breakthroughs during processing of tissue, where the tissue is selected from bone, cartilage, calcified tissue, teeth, and foreign bodies within a patient's body.

[0026] According to one aspect, an embodiment of the present disclosure provides a sound and vibration generator for sound and vibration analysis of tissue processing during surgery, said sound and vibration generator having one or more vibrating elements configured to vibrate, said sound and vibration generator being at least partially integrated into a processing means of a surgical instrument.

[0027] In some embodiments, the sound and vibration generator is at least partially integrated into the machining means formed by a grinding surface. In other embodiments, the sound and vibration generator is at least partially integrated into the machining means formed by one or more cutting edges. In some embodiments, the sound and vibration generator is integrated into the cutting edges of the machining means.

[0028] The one or more vibration elements may be configured to generate sound and vibrations by periodically striking a tissue surface or a surface of the surgical instrument. The one or more vibration elements may be fixed to an outer surface of the processing tool. The one or more vibration elements may be movable relative to the processing tool. The one or more vibration elements are one or more protrusions provided on an outer surface of the processing tool.

[0029] The one or more vibration elements may include a vibration element adapted to reach a tissue surface before reaching a surface of the processing tool, In some embodiments, the sound and vibration generator may be movable relative to a cutting edge.

[0030] The one or more vibration elements may be adapted to generate sound and vibration when the processing tool is adjacent to tissue.The one or more vibration elements may be adapted to generate sound and vibration when tissue is being processed.

[0031] In another aspect, an embodiment of the present disclosure provides a system for sound and vibration analysis of tissue processing during surgery, the system comprising a surgical instrument with processing means, a sound and vibration generator at least partially integrated into the processing means of the surgical instrument, one or more signal receivers, a computing device, and a signal measurement means, the signal measurement means comprising a controller connected to the one or more signal receivers and the computing device and configured to receive and convert generated signals measured by the one or more signal receivers into digital signals and forward the digital signals to the computing device for signal processing of the received signals.

[0032] The location of the one or more signal receivers is selected from a relationship with the surgical instrument or a relationship with tissue. The one or more signal receivers are selected from the group consisting of a non-contact microphone, a contact microphone, an accelerometer, or a force sensor. In some embodiments, the location of the one or more signal receivers with respect to tissue may be such that the one or more signal receivers are attached to tissue or may be located away from a processing point of tissue.

[0033] According to a third aspect, an embodiment of the present disclosure provides a method for sound and vibration analysis of tissue processing during surgery. The method includes generating sound and vibration by a signal and vibration generator, receiving the generated sound and vibration by one or more signal receivers, and processing the generated sound and vibration to determine at least one of a pre-breakthrough stage, a breakthrough event, a moment of transition from a first layer of tissue to a second layer of tissue, or a position of a processing tool. At least one of a pre-breakthrough stage, a breakthrough event, a moment of transition from a first layer of tissue to a second layer of tissue, or a position of a processing tool is determined by determining a change in amplitude of the sound or vibration. The change in amplitude may be an abrupt rise in amplitude, an abrupt fall in amplitude, or a shift in amplitude. The method may further include a computing device using a motion speed of a surgical tool in processing the generated sound or vibration signal.

[0034] According to a fourth aspect there is provided a computer program for sound and vibration analysis of intra-operative tissue processing, said computer program comprising instructions configured, when executed on a computing device, to cause a processor to perform a method according to the present disclosure upon sound and vibration generation by a signal and vibration generating means.

[0035] Using the sounds and vibrations generated during bone processing with a cutting tool is important to inform the surgeon and the robotic system of the position of the cutting tool relative to the bone borders to prevent damage to the soft and sensitive tissues underneath the bone or inside the passages and cavities such as blood vessels, nerves, sinuses, etc. In addition to protecting sensitive tissues during bone processing, signal analysis can be used to improve and optimize the cutting process. For example, the speed can be increased in safe areas to resect bone and decreased when the bone thickness is reduced. These advantages can be exploited in manual and robotic bone processing procedures in various tissue processing scenarios, such as no cut (air cutting), far from the border, close to the border (thinned), and openings in the bone (breakthrough).

[0036] The sounds and vibrations generated during tissue surgery (processing) with a cutting tool comprising a signal and vibration generator according to embodiments of the present disclosure may be as follows: Cutting sounds and vibrations of tissue (e.g. bone or other hard tissue) are emitted from the tissue due to friction and bone fragments breaking sounds and vibrations resulting from the interaction between the bone and the sharp cutting edge. In such embodiments, the signal and vibration generator according to embodiments of the present disclosure is configured to function as a signal amplifier. In some embodiments, the sounds and vibrations are generated by the signal and vibration generator according to the present disclosure. For example, the vibrations and sound response of the bone are excited by an impact excitation of the signal and vibration generator. The signal and vibration generator is configured to excite the tissue by, for example, impacting it every revolution. The sounds and vibrations emitted in response to the impact from the bone are then analyzed. The excitation is performed in a controlled and reproducible manner, unlike cutting sounds, which are random and unreliable as they are influenced by multiple factors.

[0037] In some embodiments, the sounds and vibrations are emitted by the signal and vibration generator mechanism, e.g., generated by the movement of internal components of the signal and vibration generator mechanism. For example, rotating or vibrating subcomponents of the signal and vibration generator impact each other at a specific frequency that depends on the rotation or vibration speed of the motor. The amplitude of these vibrations also depends on the type of tissue with which the generator interacts.

[0038] Throughout this disclosure, "at least partially incorporated" refers to the sound and vibration generators being attached to the processing means of the surgical instrument, or the sound and vibration generators being external to, internal to, or partially incorporated within said processing means.

[0039] Existing tools do not generate sufficient vibrations for cutting because the bone removal rate is very small and the cut is fine. Adding the sound and vibration generator of the present disclosure to such tools allows the position of the surgical tool to be analyzed. In bone, different layers have different properties (e.g. damping and hardness). This can be used to understand the position of the surgical tool as well as to evaluate the type of tissue being operated (processed). Furthermore, the relative position of the surgical tool compared to the tissue provides insight into the breakthrough situation where the processing tool of the surgical tool penetrates to the underlying tissue. Adding the sound and vibration generator provides a clear indication in a timely manner before breakthrough occurs. This is made possible by exciting vibrations in a controlled manner in the bone. As the bone thins, a clear signal is displayed and the occurrence of breakthrough can be predicted.

[0040] Furthermore, signals generated during surgery (machining) and the transitions between different materials and tissue layers can be used as position feedback from the machining point for robotic applications.

[0041] The operation (processing) of tissue and the interaction of the sound and vibration generator with the tissue induce vibrations in both the tissue and the surgical instruments. The vibrations of the tissue and the moving parts cause the air molecules to vibrate, generating sound waves.

[0042] During surgery and the interaction of surgical instruments with tissue, there are two sources of sound and vibration.

[0043] First, when processing tissue with a moving surgical tool, sound and vibrations are generated due to the interaction of the processing tool with the tissue. Tissue debris is gradually removed in the form of small chips that are scraped off from the tissue. Furthermore, vibrations and sound are generated due to friction between the processing tool and the tissue surface.

[0044] Second, the sound and vibration generator of the surgical instrument periodically strikes (collides or impacts) the tissue a certain number of times per operating cycle. The collisions occur periodically a certain number of times per operating cycle (e.g. one revolution for a rotating tool or one cycle for a reciprocating or oscillating tool) depending on the number of vibration elements and the operating speed of the surgical instrument. This generates vibrations and sounds of a certain frequency. In this way, the vibration excitation is controlled and repeatable. This is different from cutting sounds, which are random and unreliable since they are influenced by multiple factors such as cutting speed, bone properties and operator performance.

[0045] For example, assuming a rotary surgical instrument having two independent vibrating elements rotates about the central axis of the surgical instrument at 60,000 revolutions per minute or a rotational frequency of 1000 Hz, with the vibrating elements impacting the tissue surface twice per revolution, vibrations and sound with a frequency of 2000 Hz will be generated.

[0046] Such a sound and vibration generator with a vibration element interacts with the tissue independent of the processing tool. In some embodiments, the vibration element is configured as a surface protrusion on the processing tool surface. In other embodiments, the vibration element is arranged so that it can reach the tissue surface before the processing tool surface. This allows the vibration element to interact with the tissue even when the processing tool (e.g. the head of a burr) is adjacent to the tissue. Thus, the generation of vibrations and sounds in the tissue and the surgical tool is not limited to when the tissue is being operated on. In this configuration, the sound and vibration generator generates sounds and vibrations in the tissue and the surgical tool during the operation and when the processing tool is adjacent to the tissue before and after the operation. The advantage of this is that the signal analysis system can evaluate the condition of the tissue even when the tissue is not being operated on (processed). Furthermore, the onset of this signal can be used as a warning to the surgeon that the surgical tool is approaching the tissue in cases of poor visibility or minimally invasive procedures.

[0047] Additionally, in a robotic system, it can be used as an indication to the robotic system to calibrate the position of the surgical tool relative to the tissue.

[0048] The vibrating element vibrates the tissue continuously. When the tissue becomes very thin (approximately 0.3 mm), it starts to produce a clear signal indication to the processing tool. In this situation, an abrupt change in vibration and sound patterns is detectable, similar to the change from one layer of bone to another with different properties. This effect can be used to determine the location of the processing tool near the boundary and to predict the occurrence of breakthrough before and during its occurrence. For example, when a surgical tool transitions from cortical bone to cancellous bone, or from dental enamel to dentin, the vibration and frequency patterns change significantly.

[0049] The sound and vibration generator with a vibrating element vibrates the tissue as well as the surgical instrument. The vibrating element may be fixed or movable. The movable element is configured to impact a hard surface of the surgical instrument, thereby generating additional sound and vibration, further facilitating signal analysis. The advantage of the amplified vibration and sound is that the signal is easier to analyze and the reliability of the signal analysis system is greatly improved. A resilient part such as a spring, elastomer, etc. may be placed under the vibrating element, thereby facilitating the movement of the vibrating element. The vibrating element may be pin-shaped, ball-shaped, wire-shaped, flap-shaped, or ring-shaped, with or without internal protrusions, and may have one or more surface patterns such as dots, spirals, linear patterns, or combinations thereof. The vibrating element and the contact surface are selected from hard metals to produce optimal sound and vibration.

[0050] The sound and vibration generator signals can be processed together with the signals from operating on the tissue or can be processed independently, and the correlation of these two signals provides additional information regarding the position of the surgical tool and the condition of the tissue.

[0051] As previously mentioned, sound and vibration generators provide surprising benefits by amplifying the sound and vibration signals generated during tissue processing, thus more accurately determining when to stop processing the tissue to avoid damage to the underlying tissue. Some versions of surgical instruments, such as diamond burrs and oscillating saws, generate very little vibration, which can be problematic.

[0052] Signal analysis to predict the location of the cutting tool in the bone. The amplitude of the signals at the frequency of the impact excitation, the natural frequency of the bone layer and their harmonics increases significantly with thinning of the bone layer and reaches a maximum before crack growth in the thin layer.

[0053] The signal analysis system is configured to detect a thin layer of cracking, which is an additional indication that a breakthrough is occurring.

[0054] The signal indications and cutting sounds associated with the thin bone layer and breakthrough begin to disappear as the surgical instrument passes through the thin bone layer (breakthrough).

[0055] In addition to breakthrough detection, sound and vibration signals can be used to recognize the type and structure of tissue being processed, and can also signal the transition from one tissue type to another, or from one layer of tissue to another.

[0056] Processing algorithms can use the correlation between frequency and amplitude in different layers of the bone to predict the position of the surgical tool within the bone and the mechanical properties of the tissue that will interact with the cutting tool. Sudden changes in the signal's amplitude or switching from one frequency band to another can determine the position and physical properties.

[0057] Different types of bone, such as cancellous and cortical bone, marrow and enamel, and dental cavities, have different density and hardness characteristics that affect their vibration behavior. Cortical bone (the dense outer surface of bone that forms a protective layer around the internal cavity) generates vibrations and sounds of significantly higher amplitudes than cancellous bone (characterized by a spongy, porous, honeycomb-like structure and typically found at both ends of long bones) and marrow (the spongy material found in the center of bones). The vibration behavior of tissues and the transition from one layer to another can be detected by vibrations and sounds of bones and surgical instruments. [Detailed description of the drawing]

[0058] 1, one embodiment of an audio analysis system configuration is shown, which captures cutting sounds with a microphone, receives the microphone output with a data acquisition system (DAQ) and converts it into an analyzable digital / analog signal, receives the digital / analog signal, analyzes the digital / analog signal, and provides the analysis results to a user interface.

[0059] Referring to Fig. 2, a surgical tool 100 is shown. In this embodiment, the surgical tool 100 is a burr. The surgical tool has a processing tool 102 having at least one cutting edge 104. The processing tool 102 has a spherical shape. The processing tool 102 is attached to a mounting means 106. Additionally, the processing tool 102 at least partially incorporates a sound and vibration generator 110. The sound and vibration generator 110 comprises a vibrating element 112, in this embodiment a ring. Axis A indicates the axis of rotational movement of the surgical tool 100.

[0060] Referring to Fig. 3, the head of the bur is depicted, showing the vibration element 112 as a movable ring and the internal step 202. The vibration element 112 vibrates during interaction with tissue and periodically impacts the step 202. The impact between the vibration element 112 and the step 202 generates sound and vibration in the surgical tool. Also, the impact between the vibration element 112 and tissue generates sound and vibration in the tissue. An elastic element 204 disposed between the vibration element 112 and the processing tool 102 facilitates the oscillatory motion of the vibration element 112.

[0061] Referring to FIG. 4, examples of different cutting scenarios or phases according to one embodiment are shown. A surgical instrument, in this embodiment a surgical burr, and the position of the processing means relative to the bone boundary are shown. In phase A, there is no contact between the surgical instrument and the bone and no sounds related to the cutting process or the movement of the blocking means are generated by the sound and vibration generator. In phase B, the head of the surgical instrument penetrates the bone and the cutting sounds and the blocking means sounds are easily detectable. In phase C, the cutting sounds and / or the blocking means sounds change suddenly as the head approaches the bottom of the bone or slightly breaks the bottom layer. In phase D, the head penetrates into the space below the bone layer and the detectable sounds related to the cutting process or the movement of the blocking means are low or not detectable.

[0062] Referring to Figure 5, an FFT spectrum of the device 100 is shown. The amplitude of the sound at frequencies corresponding to the ring movement (vibrating element 112) changes dramatically at several stages of the cutting process. The amplitude is indicated by the intensity of the color, with darker colors indicating higher amplitude.

[0063] Referring to Fig. 6, a system for analyzing the sounds and vibrations of processing tissue 2 during surgery is shown. The measuring means receives the generated signal measured by the signal receiver, converts the signal into digital form and transfers it to the computer system 11. The computer system 11 processes the received information and performs mathematical signal processing using dedicated software. For more accurate situation judgment, the operating speed of the surgical tools can also be used by the processing software. The results of the processing are communicated to the operator (surgeon) or to the robot control system.

[0064] The signal measuring means comprises a controller device 10 connected to the powered tool 1 and one or more signal receivers 5, 6, 7. The signal receivers 5, 6, 7 are selected from a non-contact microphone, a contact microphone, an accelerometer, a force sensor and are placed at different positions relative to the surgical tool 3 and the tissue 2.

[0065] A first signal receiver 5 attached to the powered tool 1 provides detectable signals related to the sound and vibration generator and transmitted through the surgical tool 3. A second signal receiver 6 attached to the tissue measures signals generated by the processing means and the sound and vibration generator and transmitted through the tissue. A third signal receiver 7 is located, for example, 10-80 cm away from the processing point and measures sounds emitted from the tissue and the sound and vibration generator. The third signal receiver 7 can be located on the powered tool 1, on the tissue surface, on the surgeon's or patient's body, or elsewhere. A computer program for sound and vibration analysis of sounds and vibrations generated during surgery includes instructions that, when executed, enable a processor to perform the method of the present disclosure.

[0066] Referring to FIG. 7, another example of sound and vibration generation phases is shown according to another embodiment of the present disclosure.

[0067] Referring to FIG. 8, a frequency spectrum analysis of a surgical tool with a sound and vibration generator rotating at 615 Hz is shown. A significant increase in amplitude in a narrow frequency band around the tool rotation frequency, shown in dashed window 1, indicates the location of the processing tool near the bone boundary (where a thin bone layer is formed). The sound and vibration generator excites the bone layer for a long period of time, about 0.6 seconds, before the processing tool breaks through the bone (i.e., breakthrough). This period of about 0.6 seconds is shown in dashed window 2. The sound and vibration generator continues to generate a signal in a narrow frequency range for about 0.5 seconds after breakthrough, as shown in dashed window 3. The distinct sound and vibration combination from the sound and vibration generator over a period of 1.3 seconds provides sufficient reliability and reaction time for the operator and / or robotic system to react to the approaching bone breakthrough event.

[0068] Referring to FIG. 9, a frequency spectrum analysis of an existing cutting bur with a cutting edge rotating at 1250 Hz is shown. A significant increase in the amplitude of a narrow frequency band around the rotation frequency of the bur (shown in dashed window 1) is followed by a sudden increase in the amplitude of the signal in a broad frequency band for about 0.1 seconds (shown in dashed window 2) indicating the breakthrough of a thin layer. Identification of the machining means located near the bone boundary is extremely difficult, since there is no time to respond from the first detectable signal (less than 0.2 seconds). Furthermore, the machining system relies on machining sounds and vibrations that are sensitive to bone properties, making the detected indicators unreliable.

[0069] 10 is a side view of a surgical tool 100. Shown is a sound and vibration generator 110 disposed within a recess 105. Recesses 105 are disposed along a surface of the tool 102 for receiving the sound and vibration generator 110.

[0070] Referring to Figure 11, there is shown a cross-sectional view of the surgical instrument 100 of Figure 10 taken along line AA. As shown, the surgical instrument 100 has a cavity for incorporating a sound and vibration generator 110. The sound and vibration generator has a vibrating element 115. The vibrating element 115 has at least one internal protrusion 116 adapted to strike an inner surface 117 of the cavity to generate vibrations and sound.

[0071] Referring to Figure 12, there is shown a cross-sectional view along line AA of the surgical instrument 100 of Figure 10. A resilient element in the form of a spring 120 is disposed inside the recess 105 below the vibration element 115 to facilitate movement of the vibration element 115.

[0072] 13 is a side view of the surgical instrument 100. Sound and vibration generators 110a and 110b disposed on the processing means 102 are shown.

[0073] FIG. 14 is a bottom view of the surgical instrument 100 of FIG.

[0074] Referring to Fig. 15, a cross-sectional view of the surgical instrument 100 of Fig. 14 is shown along line AA. As shown, the surgical instrument 100 includes at least one recess 150 for incorporating at least one sound and vibration generator 110a. In this example, the at least one recess 150 has the form of a hole provided in the machining means 102. The sound and vibration generator 110a has a vibration element 151. An elastic element in the form of a spring 152 is disposed inside the recess 150 to facilitate the movement of the vibration element 151. The vibration element 151 is shown in an inward position abutting against an inner surface 155 of the recess 150. The vibration element 153 is shown in an outward position prior to abutting against tissue.

[0075] 16 and 17, an additional alternative embodiment of the present disclosure is shown. Surgical tool 100 is depicted with sound and vibration generating portions 160 and 170 disposed as surface protrusions on the outer surface of machining implement 102.

Claims

1. 1. A sound and vibration generator for sound and vibration analysis of tissue processing during surgery, comprising: one or more mechanical vibration elements adapted to vibrate; at least partially incorporated into the processing means of the surgical instrument; configured to amplify sound and vibration signals generated during tissue processing by said processing means; Sound and vibration generators.

2. 2. The sound and vibration generator according to claim 1, which is at least partially integrated into said machining means formed as a grinding surface.

3. 10. The sound and vibration generator of claim 1, at least partially incorporated into said processing means formed as one or more cutting edges.

4. 2. The sound and vibration generator according to claim 1, which is incorporated into the cutting edge of the processing means.

5. 4. The sound and vibration generator of claim 3, wherein the one or more mechanical vibration elements are configured to generate sound and vibration by periodically impacting a surface of the tissue or a surface of the surgical instrument.

6. 2. The sound and vibration generator of claim 1, wherein the one or more mechanical vibration elements are fixed to an outer surface of the processing tool.

7. 10. The sound and vibration generator of claim 1, wherein the one or more mechanical vibration elements are movable relative to the processing means.

8. 2. The sound and vibration generator of claim 1, wherein the one or more mechanical vibration elements are one or more protrusions provided on an outer surface of the processing tool.

9. 6. The sound and vibration generator of claim 5, wherein the one or more mechanical vibration elements are arranged to reach the surface of the tissue before the surface of the processing tool.

10. 10. The sound and vibration generator of claim 9, which is movable relative to the cutting edge.

11. 2. The sound and vibration generating device of claim 1, wherein the one or more mechanical vibration elements are adapted to generate sound and vibration when the processing tool is adjacent to the tissue.

12. 10. The sound and vibration generator of claim 1, wherein the one or more mechanical vibration elements are adapted to generate sound and vibration when the tissue is being processed.

13. 1. A system for sound and vibration analysis of tissue processing during surgery, comprising: a surgical instrument having a processing means; a sound and vibration generator according to any one of claims 1 to 12, at least partially integrated into the processing means of the surgical instrument; one or more signal receivers; a computing device; - signal measurement means; wherein the signal measurement means comprises a controller connected to the one or more signal receivers and the computing device and configured to receive and convert generated signals measured by the one or more signal receivers into digital signals and forward the digital signals to the computing device for signal processing of the received signals.

14. 14. The system of claim 13, wherein the location of the one or more signal receivers is selected from a relationship with the surgical instrument or a relationship with the tissue, and the one or more signal receivers are selected from the group consisting of a non-contact microphone, a contact microphone, an accelerometer, or a force sensor.

15. 14. The system of claim 13, wherein the computing device is configured to process the generated sounds and vibrations to determine at least one of a pre-breakthrough stage, a breakthrough event, a moment of transition from a first layer of tissue to a second layer of tissue, or a position of a processing tool.

16. 14. The system of claim 13, wherein the computing device further comprises using the operating speed of the processing tool as an aid in processing the generated sound or vibration signals.

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